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The TRICAV II clinical trial is to determine the safety and effectiveness of theTricValve® Transcatheter Bicaval System.
This trial is for patients with severe or greater tricuspid regurgitation.
*CAUTION : TricValve is an Investigational Device.
Limited by Federal (United States) Law to Investigational Use.
Learn more about the TRICAV Trial at ClinicalTrials.gov.
Tricuspid regurgitation (TR) occurs when the tricuspid valve in your heart does not close all the way, usually because the valve has dilated, or stretched, and its leaflets don’t close tightly. This allows blood to flow backwards within the heart, and if severe may cause symptoms such as shortness of breath with activity and swelling in your abdomen, legs, or veins in your neck.
What is the TricValve® Transcatheter Bicaval system?
The TricValve® is an investigational device designed for the implantation of two dedicated self-expanding biological valves without the need for open-heart surgery. The valves are implanted using a minimally invasive delivery system where your doctor places a thin tube through a vein in your leg to reach your heart to position the self-expanding valves.
See how it works. Watch the TricValve procedural animation.
This trial is intended to evaluate the safety and effectiveness of the TricValve system with Optimal Medical Therapy (OMT) compared to OMT alone in patients with severe TR
New medical devices are made available to people on a regular basis. However, before they can be offered to the public, they need to be studied for how safe they are and how well they work.
A clinical pivotal trial is a type of research conducted with volunteers that studies recently developed medications or treatments.
The TRICAV II clinical pivotal trial will evaluate the safety and effectiveness of an investigational device designed to treat severe TR and caval reflux by implanting two dedicated self-expanding biological valves in the right atrium using a transcatheter procedure (without open-heart surgery).
A transcatheter procedure will be used to implant the TricValve® system in this clinical trial.
You may receive the implant of the TricValve system while remaining on optimal medical therapy (OMT), or optimal medical therapy alone.
This clinical study will allow doctors to understand how the TricValve system works in patients like you
You will be informed of the potential risks and benefits of participating in the TRICAV II pivotal trial and given ample time to ask questions about the research. Your participation is completely voluntary.
You will be enrolled randomly in either the Test Group (receiving the TricValve system and Optimal Medical Therapy) or the Control group (receiving only Optimal Medical Therapy).
You will be monitored throughout the procedure and after implantation of the device. This will require you to come in for several follow-up visits over a 5-year period.
During the trial, you will have a team of experts—your Heart Team—to guide and support you from beginning to end.
The tests or procedures required by the research trial that would not otherwise be part of your standard care will be covered by P&F USA, Inc., the Sponsor of this trial.
You will still be responsible for the cost of your usual ongoing medical care, including deductibles and co-payments that would be billed to you or your health insurance provider.
CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use. This device is not available for marketing or commercial sale in the United States.
P & F USA, Inc. is the sponsor of the TRICAV-II Pivotal Trial.
DISCLAIMER: The material contained on this site is for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Not all products are available for use in all countries. Always seek the advice of your physician or other qualified healthcare provider.